Maharashtra FDA ex-chief accuses DCGI of delaying action against J&J

In India, it was the Maharashtra FDA that first asked J&J to find the patients and refer them for revision surgery.

Former Maharashtra Food & Drug Administration Commissioner Mahesh Zagade, who first initiated investigations into Johnson & Johnson’s faulty hip implants in 2011, has accused the office of the Drug Controller General of India (DCGI) of dragging its feet in taking action against the company despite enough evidence.

In a telephonic interview to ET, Zagade also questioned the basis on which the drug controller’s office re-issued the import licence for the articular surface replacement (ASR) hip implants even though the company had voluntarily recalled the product in 2010.

Documents on the drug controller’s website show the DCGI’s office issued a recall notice in India in December 2013, three years after the official withdrawal by the company.

The former Maharashtra FDA commissioner’s assertion comes when the health ministry said it is “deliberating” findings of an expert committee, which found J&J had provided misleading information about faults of its hip replacement products.
“If the product was recalled all over the world, how did the licensing authorities give the import licence for the product in India? The government machinery was also responsible,” said Zagade.

During several consultative meetings in 2012 and 2013, Zagade explained to the then DCGI, GN Singh, both informally and formally, about the seriousness of the matter, which had already led J&J to pay compensation to patients who experienced adverse effects after the replacement.

“I told the DCGI at least patients here should be found and sent for re-surgery. But the response of DCGI was not forthcoming,” Zagade said.

An email sent to the DCGI office on their role in issuing import licence to the company remained unanswered.

The controversy dates back to 2010, when DePuy Orthopaedics, a J&J subsidiary, withdrew all ASR hip implants that it had imported since 2003, after a UK study found the device had a high failure rate.

In India, it was the Maharashtra FDA that first asked J&J to find the patients and refer them for revision surgery. When the company said it couldn’t find the patients, the FDA filed a criminal case against it and later recommended that the case be taken up by the central investigative agencies considering the seriousness of the issue.

Given that the role of government bodies including the Central Drugs Standard Control Organisation and other state FDA and licensing authorities needed to be probed, Zagade had sought the involvement of larger investigative authorities.

His sentiments were echoed by some patients who received the implants and had either suffered disabilities or had to undergo revision surgeries.

J&J had “immediately informed the DCGI about the voluntary recall,” the company had said last week in response to ET’s queries.

In an response to ET, J&J said it does not, have access to data on patients who have received an ASR hip implant due to patient confidentiality regulations.

"As ASR patient data is maintained by surgeons and hospitals, DePuy has been actively requesting that surgeons and hospitals reach out to their ASR patients to ensure awareness. Efforts to support ASR patients and their surgeons have been a top priority for us, and we have sent several communications to surgeons who implanted ASR hips, informing them of the recall, available support, clinical and scientific support information and the reimbursement process". a J&J spokesperson said in an response to ET.

Zagade, who headed the state FDA from September 2011to August 2014, said the re-emergence of the issue, which his office initially took up for investigation, makes him feel vindicated. The fresh furore over the hip implants broke out after an expert committee is said to have found that J&J deliberately misled the authorities.

Zagade had another word of caution: he said the formation of the committee does not have a legal mandate and the government may not have any power to enforce its recommendations. This is dilly-dallying by the government, he claimed, adding that there are enough provisions under the drugs and cosmetics laws to prosecute the offenders.

The committee's report was made available late on Tuesday, following a letter to health minister JP Nadda on Monday by five patients and their families seeking access to the executive committee’s report. They demanded participation in “any further deliberations” on action that the government plans to take in this matter.

“In spite of our attempts over several years to draw attention to the serious safety concerns with the ASR hip implant device... the response from the government for years was one of apathy and dismissiveness,” according to the letter, which ET has reviewed.

The committee’s proposed compensation of up to Rs 20 lakh per patient, based on the degree of their disability, is insufficient and would only add “insult to serious injury,” according to the five patients.

“We have suffered severe consequences – medical, financial and personal – because of the hip implant and have been forced to lead severely compromised lives,” they told the minister.

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